Millipore Launches Ground-Breaking MilliPROBE Solution to Detect Mycoplasma in Biopharmaceutical Manufacturing
Innovative solution will cut mycoplasma detection time from 28 days to four hours
BILLERICA, Mass.--(BUSINESS WIRE)--Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, today announced the launch of a new product from its ground-breaking collaboration with Roka Bioscience to develop faster, more robust tests for contaminants in pharmaceutical and biotechnology manufacturing. The MilliPROBE® Detection System for Mycoplasma is the first solution of its kind for the early detection of mycoplasma contamination in the highly regulated biopharmaceutical manufacturing industry.
"The launch of our new MilliPROBE System represents a breakthrough innovation and is the culmination of four years of collaborative work to change the way the industry tests for mycoplasma"
."The launch of our new MilliPROBE System represents a breakthrough innovation and is the culmination of four years of collaborative work to change the way the industry tests for mycoplasma," said Jean-Paul Mangeolle, President of Millipore's Bioprocess Division. "The system builds on Millipore's strength in mycoplasma risk management. It integrates our industry-leading sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated (and recently licensed to Roka Bioscience), to deliver a unique solution that addresses an immediate and critical market need. We are extremely excited about the market opportunity for the MilliPROBE System."
Mycoplasma is a small, slow-growing and self-replicating bacteria that is extremely difficult to detect and eliminate from biopharmaceutical manufacturing processes. Mycoplasma contamination can have costly consequences for biopharmaceutical manufacturers, who must often destroy an entire drug batch and shut down production facilities for an extended period when mycoplasma contamination is detected.
The MilliPROBE Detection System for Mycoplasma, the newest assay in Millipore's MilliPROBE platform aimed at rapid microbial detection, cuts detection time from between 28 and 35 days (for traditional culture-based technology) to just four hours. Faster and more robust detection enables biopharmaceutical manufacturers to test more frequently and take corrective action earlier in the production process, reducing financial risks and optimizing product yields.
"The MilliPROBE system is unique because it can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab," noted Roland Heinrich, Millipore Vice President, Process Monitoring. "It includes a novel Millipore sample preparation device designed to handle complex bioreactor samples in larger volumes than other mycoplasma testing products. It also includes Gen-Probe's new Background Reduction Technology (the first of its kind), which protects the assay from contamination that can cause false positive results-a prevalent testing problem representing substantial financial risk for customers.
"We will continue to leverage our ongoing partnership with Roka Biosciences to introduce additional MilliPROBE assays in the future," Heinrich added.
In 2005, Millipore and Gen-Probe, based in San Diego, California, formed an exclusive partnership to develop faster, more reliable and sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. In September, 2009, Millipore transferred its collaboration to Roka Bioscience, an independent company created through the spin-off of Gen-Probe's industrial assets.
Millipore (NYSE: MIL) is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore Corporation is an S&P 500 company with more than 5,900 employees worldwide. For more information, please contact Millipore Tech Service at 1-800-548-7853 or 951-676-8080 or visit www.millipore.com.
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Forward Looking Statement
The matters discussed herein, as well as in future oral and written statements by management of Millipore Corporation that are forward-looking statements, are based on current management expectations that involve substantial risks and uncertainties which could cause actual results to differ materially from the results expressed in, or implied by, these forward-looking statements.
Potential risks and uncertainties that could affect Millipore's future operating results include, without limitation, failure to achieve design wins into our pharmaceutical and biotechnology customers' manufacturing design phase for a particular drug; delay, suspension or termination of a customer's volume production; lack of availability of raw materials or component products on a timely basis; regulatory delay in the approval of customers' therapeutics; limitations on cash flow available for operations and investment due to increased debt service obligations; the inability to establish and maintain necessary product and process quality levels; reduced demand for animal-derived cell culture products; the inability to realize the expected benefits of development, marketing, licensing and other alliances; competitive factors such as new membrane or chromatography technology; the inability to achieve anticipated cost benefits of our supply chain initiatives; risks relating to our concentration of principal manufacturing operations; the inability to utilize technology in current or planned products due to overriding rights by third parties; potential environmental liabilities; conditions in the economy in general and in the bioscience and bioprocess markets in particular; foreign exchange fluctuations; reduced private and government research funding; exposure to product liability claims; and difficulties inherent in transferring or outsourcing of manufacturing operations. Please refer to our filings with the SEC, including our most recent Annual Report on Form 10-K, for more information on these and other risks that could cause actual results to differ.
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